Pryor JL et al. (2006) Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet 368: 929–937

Dapoxetine is the first selective serotonin reuptake inhibitor (SSRI) specifically developed to treat premature ejaculation. Several SSRIs used to treat psychiatric d1sorders have been prescribed off-label for premature ejaculation, as SSRIs are known to delay ejaculation. Uniquely, dapoxetine has a very short half-life of 1.2 h, which makes it suitable for on-demand use.

Pryor et al. have reported on two parallel, phase III, multicenter, randomized, double-blind, placebo-controlled trials. They assessed 2,614 men with premature ejaculation (mean age 40.5 years); 870 received placebo, 874 received low-dose dapoxetine (30 mg), and 870 received high-dose dapoxetine (60 mg; 672, 676, and 610 men completed the study, respectively). One dose of dapoxetine was taken per 24 h period, 1–3 h before anticipated sexual intercourse. Intravaginal ejaculatory latency time (IELT) was assessed at baseline and at 4, 8, and 12 weeks.

Mean IELT at baseline for all groups was ∼0.91 min, whereas mean IELTs at study end were 1.75 min, 2.78 min, and 3.32 min for men receiving placebo, low-dose dapoxetine, and high-dose dapoxetine, respectively. IELT was significantly longer for dapoxetine-treated men than for placebo-treated men, and was also longer for men who received high-dose dapoxetine than for men who received low-dose dapoxetine (both P <0.0001). Dapoxetine was effective from the first dose. Mild dizziness, nausea and syncope were described, but no severe adverse effects were reported.

Dapoxetine can delay ejaculation when given on demand, with the greatest IELT increases seen in men with the lowest baseline values.